System for managing inventory of bulk liquids

ABSTRACT

A system for managing bulk liquids for an automated clinical analyzer. The system comprises (a) at least one local reservoir for storing a bulk liquid for impending use, (b) at least one container for holding a bulk liquid before the liquid is transferred to a local reservoir, and (c) a controller for monitoring the level of a bulk liquid in a local reservoir. The local reservoir for storing a bulk liquid for impending use can be a trough. The use of troughs for storing a reagent, a diluent, or some other treating agent for impending use enables an aspirating/dispensing device having a plurality of pipettes to aspirate and dispense the reagent,diluent, or other treating agent at a high rate of throughput. The controller can monitor the level of a liquid in (a) a local reservoir for storing a bulk liquid for imminent use and the level of liquid in a (b) container for holding a bulk liquid before the liquid is transferred to a local reservoir. In the laboratory automation system described herein, the container for holding a bulk liquid before the liquid is transferred to a local reservoir can be a bottle. Other desirable features in the system include, but are not limited to, pump(s), valves, liquid level sensors.

RELATED APPLICATION

This patent is a continuation of U.S. patent application Ser. No.14/247,887, filed Apr. 8, 2014, and entitled “System for ManagingInventory of Bulk Liquids,” which is a continuation of U.S. patentapplication Ser. No. 12/487,716 (now U.S. Pat. No. 8,715,574), filedJun. 19, 2009, and entitled “System for Managing Inventory of BulkLiquids.” U.S. patent application Ser. No. 14/247,887 and U.S. patentapplication Ser. No. 12/487,716 are hereby incorporated by reference intheir entireties.

FIELD OF THE DISCLOSURE

This disclosure relates to managing the inventory of bulk liquids, and,more particularly, the managing of inventory of bulk liquids in anautomated clinical analyzer.

BACKGROUND

Automated analyzers are well-known in the field of clinical chemistryand in the field of immunochemistry. Representative examples of suchautomated analyzers include, but are not limited to, PRISM® analyzers,AxSym® analyzers, ARCHITECT® analyzers, all of which are commerciallyavailable from Abbott Laboratories, Cobas® 6000, commercially availablefrom Roche Diagnostics, Advia, commercially available from Siemens A G,Dimension Vista, commercially available from Dade Behring Inc., Unicel®DxC600i, commercially vailable from Beckman Coulter Inc., and VITROS,commercially available from Ortho-Clinical Diagnostics. Each of theseanalyzers suffers from various shortcomings, some more than others. Someof the shortcomings encountered by more than one of these automatedanalyzers include the use of large volumes of sample, the use of largevolumes of reagents, the generation of large volumes of liquid waste andsolid waste, and high costs. Some of the aforementioned automatedanalyzers are not designed so as to be able to carry out both clinicalchemistry assays and immunoassays. Some of the aforementioned automateded analyzers are not capable of being modified to suit the demands ofcertain users. For example, even if a user desires to have moreimmunoassay reagents on an analyzer and fewer clinical chemistry agentson the analyzer, or vice versa, the user cannot modify theconfiguration. Furthermore, the addition of additional immunoassaymodules and/or clinical chemistry modules to increase throughput isdifficult, if not impossible. Some of the aforementioned automatedanalyzers require a great deal of maintenance, both scheduled andunscheduled. In addition, some of the aforementioned automated analyzershave scheduling protocols for assays that cannot be varied, i.e., theassay scheduling protocols are fixed, which limits such features asthroughput. For example, modification of current assay protocols oraddition of new assay protocols may be difficult, if not impossible. TheARCHITECT® analyzers currently in use can only support six variants ofchemiluminescent microparticle immunoassay protocols. In addition, someof the aforementioned analyzers occupy a great deal of floor space andconsume large quantities of energy,

Users of automated analyzers desire the automated analyzers to have aminimal effect on laboratory operations, i.e., occupancy of small areasof floor space, reduction of quantities of liquid waste and solid waste,reduction of quantities of reagents and samples used, capability ofinteracting with existing laboratory information management systems, andsimplification of ordering of consumable items. Users of automatedanalyzers further desire more automation of processes, greaterintegration of immunoassays with clinical chemistry assays, automatedloading of reagents, automated loading of other consumable items,automated removal of waste, and automated maintenance. Users ofautomated analyzers still further desire safer and more reliableapparatus, e.g., minimal quantity of unexpected failures, minimaldown-time, minimal time required to diagnose and repair unexpectedfailures. Users of automated analyzers still further desire moretrustworthy apparatus, e.g., consistent results across a plurality ofinterconnected analyzers, internal checks for verifying all assayprocessing steps, and self-diagnosing apparatus. Users of automatedapparatus further desire quiet apparatus and environmentally friendlyapparatus.

The management of bulk liquids used by automated clinical analyzers istypically performed manually. Consumers generally replenish bulk liquidson automated clinical analyzers based on need, i.e., a low inventory.The replenishment operation could reach a frequency that demandsfrequent, time-consuming monitoring by laboratory personnel.Accordingly, it is desired to automate the aforementioned operations inorder to reduce the labor required to manage the inventory of bulkliquids in clinical analyzers.

SUMMARY

This disclosure provides a system for managing bulk liquids for anautomated clinical analyzer. The system comprises (a) at least one localreservoir for storing a bulk liquid for impending use, (b) at least onecontainer for holding a bulk liquid before the liquid is transferred toa local reservoir, and (c) a controller for monitoring the level of abulk liquid in a local reservoir.

The local reservoir for storing a bulk liquid for impending use can be atrough. The use of troughs for storing a reagent, a diluent, or someother treating agent for impending use enables an aspirating/dispensingdevice having a plurality of pipettes to aspirate and dispense thereagent, diluent, or other treating agent at a high rate of throughput.The controller can monitor the level of a liquid in (a) a localreservoir for storing a bulk liquid for imminent use and the level ofliquid in a (b) container for holding a bulk liquid before the liquid istransferred to a local reservoir. In the laboratory automation systemdescribed herein, the container for holding a bulk liquid before theliquid is transferred to a local reservoir can be a bottle. Otherdesirable features in the system include, but are not limited to,pump(s), valves, liquid level sensors.

The method described herein includes a method of reading informationfrom labels. According to this method, radio frequency identificationtags, conforming to the guidelines of ISO 14443 or ISO 15693 and ISO18000, are positioned on the items of interest, such as, for example,containers for holding reagents (alternately referred to as “reagentcontainers”), containers for holding samples (alternately referred to as“sample containers”), and micro-well plates. These tags can be read byand written to by either a moving antenna of a radio frequencyidentification reader or a stationary antenna of a radio frequencyidentification reader. Reading of radio frequency identification tagsand writing to radio frequency identification tags are controlled bysoftware. The use of radio frequency identification technology providesfaster and more reliable readings than do barcodes, and furthereliminates the hazards associated with laser scanning devices. Thesystem described herein enables tracking of micro-well plates from theinitial dispensing of samples and reagents to the final reading ofresults from the plates.

In another aspect, this disclosure provides a mechanism for loadinglocal reservoirs. The local reservoir comprises a holder for holding aplurality of local reservoirs, e.g., troughs. The holder is mounted upona support. A first lever arm and a second lever arm, one on each side ofthe support, are connected by a rod. The combination of the first leverarm, the second lever arm, and the rod allows a human operator to rotatea set of paddles. Each paddle supports one or more liquid level sensorsthat can be interfaced with receptacles for the sensors in the localreservoirs. In addition, tubes for filling and/or draining the localreservoirs are raised when the paddles are rotated to abut the localreservoirs and lowered when the paddles are rotated away from the localreservoirs.

The laboratory automation system described herein provides auser-friendly graphical user interface for enabling an operator toclosely control and monitor numerous immunoassays and/or clinicalchemistry assays. The graphical user interface can utilize fuelgauge-type liquid level indicators to simplify reading of liquid levelsin containers. The graphical user interface can utilize instructionalballoons to instruct relatively inexperienced operators in proper usageof the laboratory automation system.

The system described herein reduces the labor required to manage theinventory of bulk liquids for automated clinical analyzers. Localreservoirs are monitored and replenished automatically. Other thaninitial loading of bulk liquids, intervention by an operator is notrequired.

Architectures of prior systems, such as, for example, ARCHITECT®clinical analyzers, that utilize direct liquid dispensing, with meteringpumps, require more expensive pumps, valves, and the like, to carry outdispensing operations, and typically require priming after a containerof bulk liquid is replaced or replenished. Because it is expected thatair displacement pipetting will be used in the future to dispense bulkliquids, pumps for bulk liquids that replenish local reservoirs,including troughs, can be of lower cost, of lower volume (less than 1liter/hour)), and reduced metering. Finally valves are eliminated andonly used for maintenance procedures. This allows clinical analyzers tobe more reliable and cost less to repair.

Through the use of a liquid dispensing apparatus having a plurality ofheads for holding pipette tips, bulk liquids can be transferred byinexpensive pumps, bulk liquids can be dispensed at low volumes, andmetering is not required. The use of valves can be substantiallyeliminated, typically for use only for maintenance procedures, therebyenabling automated clinical analyzers to be more reliable and lesscostly to repair.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a top plan view of a laboratory automation system that employsbulk reagents in liquid form.

FIG. 2 is a side view in elevation o he laboratory automation systemshown in FIG. 1.

FIG. 3 is a schematic diagram of the bulk liquid handling systemdescribed herein.

FIG. 4 is a schematic diagram illustrating the system control center forthe laboratory automation system.

FIG. 5 is a perspective view of a mechanism for loading troughs thatcontain bulk reagents in liquid form.

FIG. 6 is another perspective view of the mechanism shown in FIG. 5,

FIG. 7 is a top plan view of the mechanism shown in FIGS. 5 and 6.

FIG. 8 is a partial perspective view of the mechanism shown in FIG. 5.In FIG. 8, the lever arms are shown rotated away from the troughs.

FIG. 9 is a side view in elevation of the mechanism shown in FIG. 8. InFIG. 9, the lever arms are shown rotated away from the troughs.

FIG. 10 is a perspective view of a trough suitable for holding bulkliquids.

FIG. 11 is a side view in elevation of one end of the trough of FIG. 10.FIG. 10 shows a peelable protective tape overlying receptacles forreceiving liquid level sensors.

FIG. 12 is a side view in elevation of one end of the trough of FIG. 10.FIG. 11 shows the peelable protective tape overlying the receptacles forreceiving liquid level sensors partially peeled away.

FIG. 13 is a perspective view of an alternative embodiment for attachingliquid level sensors to a trough.

FIG. 14 is an exploded perspective view of the embodiment shown in FIG.13.

DETAILED DESCRIPTION

As used herein, the expression “bulk liquid” means a liquid, typically areagent a diluent, or some other type of treating agent in liquid form,which liquid is provided in a relatively large volume, e.g., one literor greater. As used herein, the term “impending” means about to takeplace.

As used herein, the term “immunoassay;” means a biochemical test thatmeasures the concentration of a substance in a biological liquid,typically serum, using the reaction of an antibody or antibodies to its(their) antigen. An immunoassay takes advantage of the specific bindingof an antibody to its antigen. As used herein, a “chemiluminescentmicroparticle immunoassay”, alternatively referred to as“chemiluminescent magnetic immunoassay”, involves a chemiluminescentlabel conjugated to the antibody or the antigen. In this assay, amagnetic microparticle is coated with antibodies. The assay is intendedto look for antigens in the sample. A second antibody is labeled with achemiluminescent label. This second antibody is not attached to amagnetic microparticle. The antibody and antigen with attach in thefollowing order: antibody on magneticmicroparticle-antigen-antibody-chemiluminescent label. The magneticmicroparticle is then washed off. The amount of antibody-antigen-enzymeis measured by adding pre-bigger solution and trigger solution andmeasuring the light produced. This type of immunoassay produces lightwhen combined with its substrate, i.e., a specific binding member. Thechemiluminescent reaction offers high sensitivity and ease ofmeasurement. This type of immunoassay involves a noncompetitive sandwichformat that yields results that are directly proportional to the amountof analyte present in the sample. As used herein, the term “magnetic”means paramagnetic.

As used herein, the expression “clinical chemistry assay” means abiochemical test that measures the concentration of a substance thatoccurs naturally within the human body, which concentrations serves toindicate the condition or state of health of the various systems of thebody. Such a substance, often referred to as an analyte, exists withincertain expected ranges of concentration in a healthy human being.Chemistry analytes fall into one of three main categories, routineanalytes, such as for example, lipids, nutrients, chemical constituents,metabolic products, examples of which include glucose, urea nitrogentriglycerides, uric acid, enzymes, such as, for example, alanineaminotransferase, aspartate aminotransferase, lactate dehydrogenase, andamylase, and electrolytes, such as, for example, sod m, potassium, andchloride. As used herein, the expression “laboratory automation system”means a system designed to automate the processing of samples prior to,during, and subsequent to analyzing the samples. The processing includeshandling of the samples, moving the samples from a clinical analyzer toother components of the system, and storing of the samples.

As used herein, the expression “radio frequency identification” is ageneric term for technologies that use radio waves to automaticallyidentify objects, such as, for example, containers for biologicalsamples and containers for reagents for analyzing biological samples.The most common method of identification is to store a serial numberthat identifies the object, and perhaps other information relating tothe object or contents thereof, on a microchip that is attached to anantenna. The microchip and the antenna together are called a radiofrequency identification transponder or a radio frequency identificationtag. The antenna enables the microchip to transmit the identificationinformation and other information to a radio frequency identificationreader. The radio frequency identification reader converts the radiowaves reflected back from the radio frequency identification tag intodigital information that can then be passed on to computers that canmake use of it.

As used herein, the expression “radio frequency identification system”,or “MD system”, comprises a radio frequency identification tag made upof a microchip with an antenna, and a radio frequency identificationinterrogator or radio frequency identification reader with an antenna.The radio frequency identification reader sends out electromagneticwaves. The tag antenna, is tuned to receive these waves. A passive radiofrequency identification tag draws power from the field created by thereader and uses it to power the circuits of the microchip. The microchipthen modulates the waves that the passive radio frequency identificationtag sends back to the radio frequency identification reader, whichconverts the waves received by the radio frequency identification readerinto digital data.

As used herein, microchips in radio frequency identification tags can be“read-write microchips”, “read-only microchips”, or “write once, readmany microchips.” In the case of read-write microchips, information canbe added to the radio frequency identification tag or existinginformation can be written when the radio frequency identification tagis within range of a radio frequency identification reader. Read-writemicrochips usually have a serial number that cannot be written over.Additional blocks of data can be used to store additional informationabout the items to which the radio frequency identification tag isattached. These radio frequency identification tags can be locked toprevent overwriting of data or encrypted to prevent the disclosure ofproprietary data or disclosure of data that would compromise the privacyof a patient. Read-only microchips have information stored on themduring the manufacturing process. The information on them can never bechanged. Write once, read many microchips have a serial number and otherdata written to them once, and that information cannot be overwrittenlater.

Active radio frequency identification tags have a transmitter and theirown power source, typically a battery. The power source is used to runthe microchip's circuitry and to broadcast a signal to a radio frequencyidentification reader. The microchip's circuitry can possibly performsome sort of monitoring function. Passive radio frequency identificationtags have no battery. Instead, passive radio frequency identificationtags draw power from the radio frequency identification reader, whichsends out electromagnetic waves that induce a current in the tag'santenna. Semi-passive radio frequency identification tags use a batteryto run the microchip's circuitry, but communicate by drawing power fromthe radio frequency identification reader. Any of the foregoing types ofradio frequency identification tags can be used in the system of thisdisclosure.

As used herein, the expression “radio frequency identification reader”or “reader” means a device having the function of providing means forcommunicating with a radio frequency identification tag and facilitatingtransfer of data to and from a radio frequency identification tag.Functions performed by a radio frequency identification reader caninclude quite sophisticated signal conditioning, signal sorting, parityerror checking, and correction. Once the signal from a radio frequencyidentification tag has been correctly received and decoded, algorithmscan be applied to decide whether the signal is a repeat transmission,and can then instruct the radio frequency identification tag to ceasetransmitting. This type of interrogation is known as “command responseprotocol” and is used to circumvent the problem of reading a pluralityof radio frequency identification tags in a short space of time. Analternative technique involves the radio frequency identification readerlooking for radio frequency identification tags with specificidentities, and interrogating them in turn. It is within the scope ofthis disclosure to use a single radio frequency identification reader ora plurality of radio frequency identification readers. A radio frequencyidentification reader is connected to a single antenna or o a pluralityof antennas.

As used herein, the expression “aspirating/dispensing device” means adevice that has the dual functions of removing liquids from containersby suction and distributing portions of the liquids aspirated intocontainers, e.g., micro-wells of micro-well plates. Anaspiration/dispensing device that is capable of being used for he systemdescribed herein is described in U.S. Pat. No. 7,033,543, incorporatedherein by reference. As used herein, the term “pipette”, also called“pipet”, “pipettor” means a laboratory instrument used to transport ameasured volume of liquid. As used herein, the expression “micro-wellplate”, also called “microtiter plate”, “microplate”, means a flat platehaving a plurality of “wells” used as small test tubes. As used herein,the term “XYZ” refers to a device that can move in three directions afirst horizontal direction, a second horizontal direction that isperpendicular to the first horizontal direction, and a third directionthat is perpendicular to both the first horizontal direction and thesecond horizontal direction. As used herein, the expression “analysissection of the laboratory automation system” means that portion of thelaboratory automation system in which immunoassays or clinical chemistryassays or both immunoassays and clinical chemistry assays are performed.As used herein, the term “kitting” means dispensing samples and reagentsin appropriate micro-wells of a micro-well plate prior to commencingchemical reactions.

As used herein, the expression “local reservoir” means a container forholding; a bulk liquid. Local reservoirs include closed containers andopen containers. As used herein, the term “trough” means a localreservoir that is an open container.

As used herein, the term “channel” means a pipette tip. In general, thehead of an aspirating/dispensing device has 12 channels or 96 channels.

As used herein, the term “system” means a group of interrelated,interacting, or interdependent constituents forming a complex whole. Asused herein, the term “sub-system” means a subordinate system, systemthat is a component of a larger system.

As used herein, the symbol “(s)” following the name of an item indicatesthat one or more of the subject items is intended, depending upon thecontext. As used herein, the expression “and/or” is used to indicatethat either the word “and” or the word “or” can be used to connectwords, phrases, or clauses.

Throughout the specification, so far as possible, like parts orcomponents will have the same reference numerals; like parts orcomponents may have different reference numerals when required for thesake of clarity. In addition, where necessary, a micro-well plate(s) isindicated by the letter “P”. It should be noted the micro-well plates inprocessors and readers are not actually visible. However, the micro-wellplates are inside of the processors and readers and the relativepositions of the micro-well plates within the processors and readers aredesignated by the letter “P”.

Laboratory automation systems employ automated clinical analyzers, suchas, for example, automated immunoassay analyzers and automated clinicalchemistry analyzers. Automated clinical analyzers typically employaspirating/dispensing devices wherein a pipette (or pipettes) of theaspirating/dispensing device can be moved in three dimensions, i.e., twodimensions in a horizontal plane (i.e., X and Y) and one dimensionvertically (i.e., Z). The remaining components of laboratory automationsystems can be placed near to or be connected with theaspirating/dispensing device to enable the pipette (or pipettes) toobtain access to various components of the laboratory automation system.However, not all components require direct access from anaspiration/dispensing device, In some cases, micro-well plates intowhich reagents have been dispensed can be moved out of the access rangeof the aspiration/dispensing device by an optional robotic mechanism andplaced in an autonomous sub-system for further processing. Ingeneral,chemiluminescent microparticle immunoassays do not call fordispensing reagents after kitting has taken place. In contrast, clinicalchemistry assays require dispensing reagents between readings.

Depending on the desired capabilities of the laboratory automationsystem, laboratory automation sub-systems (e.g., various diagnosticassay technologies) can added to or subtracted from theaspirating/dispensing device. In addition, multiple sub-systems can beadded to the laboratory automation system to increase throughput, e.g.,one or more immunoassay sub-systems can be added to an immunoassaysub-system to increase throughput of immunoassays, or one or moreclinical chemistry assay sub-systems can be added to a clinicalchemistry assay sub-system to increase throughput of clinical chemistryassays.

The desired components of laboratory automation systems can bepositioned in numerous arrangements. FIGS. 1 and 2 illustrate asub-system of laboratory automation system. The sub-system shown inFIGS. 1 and 2 is an analysis section of a laboratory automation system.Therein immunoassays are integrated with clinical chemistry assays. Thissub-system can also perform a relatively high number of assays per unitof time. A system for managing the inventory of reagents can be designedto place reagent containers into reagent container carriers, after whichplacement, these reagent container carriers will be routed to theanalysis section of the laboratory automation system, where they will bediverted into the correct local queue. Reagent containers, reagentcontainer carriers, and queues are described in detail in U.S.application Ser. No. 12/257,495, filed Oct. 24, 2008, and entitledAUTOMATED ANALYZER FOR CLINICAL LABORATORY, incorporated herein byreference.

A reagent inventory management system can be added to the laboratoryautomation system described herein. A typical reagent inventorymanagement system includes an operator interface for the loading ofboxes of reagents and other supplies, radio frequency identificationsystem for identification of inventory and tracking, robotic mechanismsfor loading containers onto the track system and removing containersfrom the track system, decapping equipment, refrigeration equipment, andinformation technology connections to laboratory analyzers and vendors.

Not shown in FIGS. 1 and 2, but necessarily present, is a control unitfor handling information in the laboratory automation system. Thecontrol unit also provides the commands to the various roboticmechanisms, which carry out the automated functions of the laboratoryautomation system. It is expected that the control unit can be apersonal computer.

A central reagent storage area (not shown) can provide a substantialinventory of reagents these reagents can be transported to the tracksystem (not shown) or the analysis section of the laboratory automationsystem as required. Means of transportation suitable for transportingreagents from the central storage area to an input/output module (notshown) include, but are not limited to, gantries, endless conveyorbelts, and robotic mechanisms. The central reagent storage system, thetrack system, the input/output module are described in detail in U.S.application Ser. No. 12/257,495, filed Oct. 24, 2008, and entitledAUTOMATED ANALYZER FOR CLINICAL LABORATORY, previously incorporatedherein by reference.

Adjacent to the track system is at least one analysis section 10 of thelaboratory automation system. Depending upon the size of the tracksystem, more than one analysis section 10 can be employed.

Referring again to FIGS. 1 and 2, the analysis section 10 has four majorsub-sections, namely a sub-section 12 for retaining samples and reagentsthat are to be used in the assays, at least one sub-section 14 forretaining disposable components for the equipment needed to introduceand manipulate samples and reagents into reaction vessels, e.g.,micro-well plates, at least one sub-section 16 for supportinginstruments needed to carry out immunoassays, and at least onesub-section 18 for supporting instruments needed to carry out clinicalchemistry assays. The sub-sections 16 and 18 are not required to bedirectly accessible to an aspiration/dispensing device and can utilizekitted micro-well plates. However, the sub-sections 16 and 18 generallyhave an aspiration/device that has direct access to micro-well plates.FIG. 2 shows that the analysis section 10 is divided among three levels.The uppermost level 20 supports samples in containers, reagents incontainers, and disposable items, all of which need to be accessed byaspirating/dispensing devices. The lowermost level 22 supports liquidwaste material and sub-systems that need to be accessed by a roboticgripping mechanism. The middle level 24 supports containers for bulkliquids that are loaded by an operator and sub-systems that need to beaccessed by a robotic gripping mechanism.

An area 26 for holding sample containers, e.g., sample tubes, ispositioned at one end of the analysis section 10. As shown in FIG. 1,the area 26 is capable of holding 108 sample tubes (6 rows, 18 sampletubes in each row). A fewer or greater number of sample tubes can beaccommodated, if so desired. Adjacent to the area 26 is an area 28 forholding reagent containers. The area 28 is a refrigerated area. Thereagent containers typically have radio frequency identification tagsattached thereto. As shown in FIG. 1, the area 28 is capable of holding180 reagent containers. For example, the area 28 is capable of holding108 reagent containers for immunoassays and 72 reagent containers forclinical chemistry assays. A fewer or greater number of reagentcontainers can be accommodated, if so desired. A radio frequencyidentification reader not shown) is positioned below the deck 20 a ofthe uppermost level 20. The purpose of the radio frequencyidentification reader is to read and to update radio frequencyidentification tags on reagent containers and sample tubes when anaspirating step is carried out or a scan inventory operation is carriedout.

The uppermost level 20 of the analysis section 10 is preferably elevatedto a level sufficient o accommodate a radio frequency identificationreader (not shown) for reading information from radio frequencyidentification tags (not shown)) attached to reagent containers. Radiofrequency identification readers suitable for use herein are describedin U.S. application Ser. No. 11/495,430, filed Jul. 28, 2006, andentitled SYSTEM FOR TRACKING VESSELS IN AUTOMATED LABORATORY ANALYZERSBY RADIO FREQUENCY IDENTIFICATION and in U.S. application Ser. No.12/274,479, filed Nov. 20, 2008, and entitled SYSTEM FOR TRACKINGVESSELS IN AUTOMATED LABORATORY ANALYZERS BY RADIO FREQUENCYIDENTIFICATION, both of which are incorporated herein by reference.

In order to implement the radio frequency identification systemdescribed herein, a radio frequency identification tag can be positionedon the lowermost portion of a container, a reagent container 30, or on acontainer carrier, e.g., a sample container carrier (not shown). It isoften desirable to position an encapsulated radio frequencyidentification tag on the lowermost portion of a container. In the caseof a sample container 32, a radio frequency identification tag can bepositioned on the sample container carrier.

The radio frequency identification system includes at least onestationary radio frequency identification reader. In order for the atleast one radio frequency identification reader to read the data fromthe radio frequency identification tag associated with a container, orwith a container carrier, the container,or the container carrier, iscaused to move to a position proximate to, and preferably in registerwith, the least one radio frequency identification reader so that theinformation from the radio frequency identification tag can be read withan amount of noise and interference from nearby radio frequencyidentification tags on other containers, or on other container carriers,that are insufficient to adversely affect the integrity of the data readby a radio frequency identification reader. In this embodiment, atransmission sub-system need not be provided to enable the at least oneradio frequency identification reader to move among the containers andthe container carriers.

There are at least two days to implement the foregoing embodiment of thestationary radio frequency identification reader. According to a first gay, the sample containers and the reagent containers, or the samplecontainer carriers and the reagent container carriers, can betransported to a position proximate to at least one stationary radiofrequency identification reader, whereby the stationary radio frequencyidentification reader tags on the containers, or on the containercarriers, can be read by the at least one stationary radio frequencyidentification reader. According to a second way, a plurality ofantennas, which are traces on a printed circuit board, function asseparate stationary radio frequency identification readers. Theseantennas can receive separate collections of data. In a preferredembodiment of a reader for reading radio frequency identification tags,a single printed circuit board has a plurality of antennas under thereagent storage area and the sample storage area. The length of theantenna is important, because the length determines the relationshipwith the radio frequency used. The length of the antenna corresponds tosome multiple of wavelength of the radio frequency energy, e.g.,one-half wavelength, one-quarter wavelength.

The printed circuit board for the radio frequency identification systemcan provide connections for antennas and a means for selecting thoseantennas one at a time. For example, the radio frequency identificationsystem can have external connections for several remote readinglocations, such as the micro-well plate rotator, pre-treatment area,magnetic particle processor, luminescence reader(s), absorbancereader(s), inventory reading locations, and locations on the local queueand transport track. By reading the antennas at these remote locations,a micro-well plate can be tracked throughout the laboratory automationsystem and provide a chain of custody.

Another radio frequency identification reader, which is stationary,reads radio frequency identification tags on micro-well plates. The useof radio frequency identification readers makes it possible toefficiently and tightly pack reagent containers 30 and sample containers34 in the sub-section 12 of the analysis section 10 of the laboratoryautomation system. The use of radio frequency identification readers andradio frequency identification tags make it possible to include a higherdensity of data on a container, relative to the amount of data that canbe applied by means of barcodes. Furthermore, if writable radiofrequency identification tags are used the data on the radio frequencyidentification tags can be updated to reflect changes that have takenplace with respect to the contents of the containers equipped with theradio frequency identification tags. The radio frequency identificationsystem can provide an interface to personal computer.

A radio frequency identification reader can read and update radiofrequency identification tags on reagent containers 30 and on samplecontainers 32, or on sample container carriers (not shown), whenaspirating of a portion of the reagent or a portion of the sample scarried out or an operation for scanning the items in inventory isinitiated. Information of the type shown in TABLE 1 can be updated onthe radio frequency identification tags by the radio frequencyidentification reader.

TABLE 1 Class of data Specific data Tag identifier Unique identifier forcontainer Manufacturing data (a) Revision number(s) of reagent(s) (b)Serial number(s) of reagent(s) (d) Component identifier(s) (e) Lotnumber(s) of reagent(s) (f) Stability/expiration data for reagent(s) (g)Times/dates of manufacture of reagent(s) (h) Configuration(s) ofassay(s) (e.g., number of reagent containers needed) (i) Number of testsin container(s) (j) Associated components of assay(s) (k) Calibrationdata for assay(s) Shipping and storage (a) Temperature(s) of reagentduring shipping data (b) Times/dates of shipping movements and storageperiods (c) Locations and dates of storage periods Analyzer and usagedata (a) Times/dates of opening(s) of reagent container(s) (b) Number ofaspirations from reagent container(s) (c) Carryover and potentialcontamination or dilution of reagent(s) or sample(s) (d) Encryptionalgorithms for protection of data (e) Other algorithms to ensureintegrity of data (f) Chain of custody for operations performed onmicro-well plates, reagent containers and sample containers; formicro-well plates, dispensing of samples, reagents(s), incubationtemperature, processing, and readings; for reagent containers, date ofmanufacture, date of shipping, date of loading in reagent inventorymanagement system, date of opening, date of loading into analyzer,aliquots removed and remaining, cumulative carryover, expiration date;for sample containers, draw date, patient, doctor, technicians, testorders, centrifugation, decapping, aliquots removed, cumulativecarryover, resealing, entry into storage

An area 34 located in front of the analysis section 10 of the laboratoryautomation system can be used as a radio frequency identification readzone for micro-well plates in order to track the micro-well plate forchain of custody purposes. By this means, analytical results can betraced to the micro-well plate in which a given assay was performed. Asystem for utilizing radio frequency identification tags and radiofrequency identification readers is described in U.S. application Ser.No. 11/495,430, filed Jul. 28, 2006, and entitled SYSTEM FOR TRACKINGVESSELS IN AUTOMATED LABORATORY ANALYZERS BY RADIO FREQUENCYIDENTIFICATION and in U.S. application Ser. No. 12/274,479, filed Nov.20, 2008, and entitled SYSTEM FOR TRACKING VESSELS IN AUTOMATEDLABORATORY ANALYZERS BY RADIO FREQUENCY IDENTIFICATION, both of whichhave been previously incorporated herein by reference.

A first area 36 for holding solid waste is positioned at the far left ofthe system second area 38 for holding solid waste is positioned adjacentto an upright brace of the structure supporting the upper level 20 andthe middle deck 24 of the system. Solid waste includes pipette tips,micro-well plates, empty reagent containers, and tip combs used inimmunoassay processors. An area 40 for holding reusable, disposablepipette tips is positioned on the upper level 20 adjacent to the secondarea 38 for holding solid waste. Disposable pipette tips can be reusedfor aspirating and dispensing the same reagent or for aspirating anddispensing the same sample. A pre-treatment and/or dilution area 42 ispositioned adjacent the area 40 for holding reusable, disposable pipettetips. A small percentage of samples require pretreatment or dilutionoperations. Pre-treatment involves preparing a sample for testing of thesample by means of an immunoassay or a clinical chemistry assay orextracting from a sample an appropriate component for testing of thecomponent by means of an immunoassay or a clinical chemistry assay.Dilution reduces the concentration of a component in a sample so thatthe component can be analyzed within the dynamic range applicable to theimmunoassay analyzer or clinical chemistry analyzer. Pre-treatment stepsand dilution steps are carried out prior to immunoassay processing orclinical chemistry assay processing.

A kitting area 44 for kitting immunoassays is positioned between an area46 that includes local reservoirs, i.e., the storage area for bulkliquids for impending use, and the area 40 for holding reusable,disposable pipette tips. Additions of sample, reagent, buffer,pre-trigger solution for up to twelve (12) immunoassays can be carriedout in the kitting area 44 for kitting immunoassays. A micro-well plate,designated in general by the letter “P”, to which samples, reagents,buffers, and pre-trigger solutions have been added can then betransferred to an immunoassay processor 48 a, 48 b, 48 c, or 48 d, forimmunoassay processing. An immunoassay processor suitable for use hereinis described in greater detail in U.S. application Ser. No. 11/923,828,filed Oct. 25. 2007 and entitled METHOD OF PERFORMING ULTRA-SENSITIVEIMMUNOASSAYS, and U.S. application Ser. No. 12/257,495, filed Oct. 24,2008, and entitled AUTOMATED ANALYZER FOR CLINICAL LABORATORY, both ofwhich are incorporated herein by reference. Clinical chemistry samplescan be dispensed in the kitting area 44 for kitting immunoassays whenthat area 44 is not being used for kitting immunoassays. Additions ofsamples for four (4) to sixteen (16) patients can be dispensed in thekitting area 44. A plate rotator 50 can rotate the micro-well plate 90°for addition of clinical chemistry reagents. The storage area 46 forbulk liquids for impending use is positioned adjacent the plate rotator50. In the storage area 46 for bulk liquids for impending use, troughs54 can be used to store liquid reagents in bulk for immunoassays andliquid reagents in bulk for clinical chemistry assays prior to impendinguse. Radio frequency identification readers can be used to read andupdate radio frequency identification tags attached to micro-well platesto record the chain of custody of the micro-well plates. A clinicalchemistry assay processing area. 56 is positioned on the upper level 20and on the middle level 24. Absorbance readers 58 a, 58 b can be used tointerleave reading with additions of various reagents. A loading area 60for micro-well plates is positioned at the far left of the analysissection 10 and above the first area 36 for holding solid waste.Micro-well plates are stored in the area 60 prior to use. A loading area62 for tip combs is positioned adjacent to the loading area 60 formicro-well plates and above the first area 36 for holding solid Taste.Tip combs are stored in this area prior to use. Tip combs are disposableitems used with certain types of immunoassay processors, morespecifically, immunoassay processors employing separation of reactioncomponents by means of magnetic particles. A loading area 64 fordisposable pipette tips is positioned adjacent to the loading area 62for tip combs and above the first area 36 for holding solid waste. Racksfor disposable pipette tips can be used to store disposable pipette tipsprior to use. Further description of the various items located in theaforementioned areas can be found in U.S. application Ser. No.12/257,495, filed Oct. 24, 2008, and entitled AUTOMATED ANALYZER FORCLINICAL LABORATORY, previously incorporated herein by reference.

As mentioned previously with respect to FIG. 2, it can be seen theanalysis section 10 is divided into three levels 20, 22, and 24, wherebythe quantity of floor area required for the components of the analysissection 10 of the laboratory automation system can be reduced. Inaddition, the multiple-level configuration makes it easier to have someimmunoassay analyzers dedicated to routine testing and some immunoassayanalyzers dedicated to STAT testing. The sample containers 32, e.g.,sample tubes, and the reagent containers 30 are positioned on theuppermost level 20. Absorbance readers 58 a, 58 b for clinical chemistryassays are positioned on the upper level 20 and the middle level 24, andimmunoassay processors 48 a, 48 b, 48 c, and 48 d for immunoassayprocessing are positioned on the middle level 24 and the lowermost level22.

A luminescence reader(s) 72 for immunoassays is (are) positionedseparate from the immunoassay processors 48 a, 48 b, 48 c, 48 d at thesub-section 16 of the analysis section 60. The luminescence reader(s) 72read the results of the immunoassay from the micro-well plates after thereaction mixtures have been processed in the immunoassay processors 48a, 48 b, 48 c, 48 d. The micro-well plates can be transferred from theimmunoassay processor(s) 48 a, 48 b, 48 c, 48 d to the luminescencereader(s) 72 by means of a conveyor belt (not shown). Alternatively, themicro -well plates can be transferred from the immunoassay processing(s)48 a, 48 b, 48 c, 48 d to the luminescence reader(s) 72 by means of arobotic mechanism. Luminescence readers suitable for use herein arecommercially available under such trade names as Molecular Devices LMaxII 384 and Thermo Scientific Luminoskan® Ascent. The items shown in FIG.2 are described in greater detail in U.S. patent application Ser. No.12/257,495, filed Oct. 24, 2008, and entitled AUTOMATED ANALYZER FORCLINICAL LABORATORY, incorporated herein by reference.

A robotic gripping device 74 is capable of moving vertically by means ofa threaded screw 76. Attached to the robotic gripping device 74 is a nut(no(shown) that enables the robotic gripping device 74 to movevertically along the threaded screw 76. Movement of the nut can beactuated by a motor (not shown), typically a stepper motor. The roboticgripping device 74 is further capable of moving in a horizontaldirection along tracks 78 and 80, which are dedicated to the roboticgripping device 74. The robotic gripping device 74 can be designed tohave features to enable telescoping movement and rotational movement.The telescoping feature enables the robotic gripping device 74 to beextended or retracted in order to reach positions located between thefront of a clinical analyzer and the rear of a clinical analyzer. Therotational feature facilitates the gripping, raising, lowering andplacing of micro-well plates in positions desired. It should be notedthat the analysis section 10 can employ more than three levels or fewerthan three levels. Also shown in FIGS. 1 and 2 are stacker drawers 82,84, 86, 88, and 90 for storing and dispensing disposable items, such as,for example, micro-well plates, tip combs for immunoassay processors,and disposable pipette tips. The use of stacker drawers 82, 84, 86, 88,and 90 enables the system to draw supplies from stacks loaded by anoperator. Such stacks result in reduction of floor space requirements.Stacker drawers 82, 84, 86, 88, and 90 make it possible to storeconsumable items vertically. The analysis section 10 also has anaspirating/dispensing device 92 for aspirating and dispensing reagents,samples, and bulk liquids. The aspirating/dispensing device 92 is an XYZdevice that is capable of moving in three directions. Theaspirating/dispensing device 92 need not have the capability offunctioning as a gripping device for reagent containers or micro-wellplates or both containers and micro-well plates. However, thiscapability can enhance the automated features of a laboratory automationsystem. On the lowermost level 22, positioned adjacent to the area 36for holding solid waste, is an area 94 for holding liquid waste. Liquidwaste includes waste from maintenance procedures.

Sample containers, reagent containers, radio frequency identificationreaders, kitting immunoassays, kitting clinical chemistry assays,immunoassay processors, micro-well plates, tip combs, disposable tipsare described in greater detail in U.S. application Ser. No. 12/257,495,filed Oct. 24, 2008, and entitled AUTOMATED ANALYZER FOR CLINICALLABORATORY, previously incorporated herein by reference. U.S.application Ser. No. 12/257,495 also describes a track system suitablefor a laboratory automation system. Also described in greater detail inU.S. application Ser. No. 12/257,495, filed Oct. 24, 2008, are clinicalchemistry analyzers and immunoassay analyzers. Still further describedin greater detail in U.S. application Ser. No. 12/257,495, filed Oct.24, 2008, are aspirating/dispensing devices and robotic grippingdevices.

Bulk liquids are contained in local reservoirs, such as, for example,troughs, so that they will be available for dispensing by a roboticdispensing device. Proper levels of liquid in local reservoirs ortroughs can be maintained by an operator. However, access to replenishbulk liquids would not be continuous. Accordingly, replenishment of bulkliquids would be scheduled, because a moving dispensing device wouldsubject the operator to injury. In addition, the frequency ofreplenishment activities would be inconvenient for operators.

Referring now to FIG. 3, a sub-system 100 for replenishing bulk liquidscomprises a bulk liquid handling controller 102, which interfaces with aplurality of channels, each channel dedicated to a different bulkliquid. Referring now to FIG. 3, the controller 102 for handling bulkliquids comprises a central processing unit, memory, interfaces toliquid level sensors, motor controllers, other hardware components, andan interface to a real-time controller. A trough 104 for a bulk liquidis typically formed from a polymeric material that is resistant tocorrosion. The dimensions of a trough 104 having a volume ofapproximately 100 milliliters can be approximately 1 inch wide×4.5inches long×2 inches deep. A container 106 for a bulk liquid istypically formed of a polymeric material that is resistant to corrosion.The dimensions of a container 106 for bulk liquid having a volume ofapproximately 1 liter can be approximately 7 inches deep×2.5 incheswide×4.5 inches long. A waste container 108 or drain (not shown) istypically formed of a polymeric material that is resistant to corrosion.The dimensions of a waste container or a drain having a volume ofapproximately 10 liters can be approximately 15 inches wide×7 incheshigh×9 inches deep. An electronic switching valve 110 for selecting thewaste container or the drain can be a two-way valve and is normallyconnected to the container for bulk liquids. Upon a maintenanceprocedure, the valve is switched to the waste container or drain, andthe pump is reversed, thereby pumping liquid from the local reservoir,or trough, into the waste container or the drain. Instead of a switchingvalve 110, a first check valve (not shown) can be used to only allowliquid to be drawn from a container for bulk liquids, and a second checkvalve (not shown) can be used to only allow liquid to enter the liquidwaste facility, either a container or a drain. Thus, an active valve canbe eliminated when the direction of the pump is reversed. A pump 112 fortransferring small, unmetered volumes of liquids is typically areversible, brushless DC motor-driven peristaltic pump with replaceabletubing.

Liquid level sensing requirements for local reservoirs and troughspresent several compatibility issues. Compatibility issues arise fromthe interactions between the materials constituting the bulk liquids andthe materials from which liquid level sensors are constructed. Onaccount of compatibility issues, a non-intrusive liquid level sensor ispreferred. A non-intrusive sensor is a sensor in which the level ofliquid can be determined without having the sensor contact the liquid. Non-intrusive sensors suitable for use herein are commercially availablefrom Gems Sensors & Controls, Plainville, Conn. and Zevex, Inc., SaltLake City, Utah. Non-intrusive liquid sensors commercially availablefrom Gems Sensors & Controls are sold under the trademark “ExOsense”.Additional information relating to non-intrusive liquid level sensorscan be found at the world wide web at http://www.gemssensors.com/ andhttp://www.zevex.com/sensing/pointlevel/, both of which are incorporatedherein by reference. Capacitative sensors are not sufficiently stablewhen used in the absolute mode. Piezo-resonant sensors are capable ofsensing the level of liquid through the wall of a container or trough.The liquid level sensor can be attached to a wall of a container ortrough by means of an adhesive, such that the liquid level sensor iscompressed against an interface material,which is positioned between theliquid level sensor and the wall of the container or trough. Theinterface material provides a signal path for the liquid level sensor.Each reservoir and trough preferably has three liquid level sensors: alow level sensor, a full level sensor and an overfull level sensor. Thesystem for handling bulk liquids will maintain the level of liquidbetween the low level sensor and the full level sensor. If an overfulllevel sensor is triggered, the system for handling bulk liquids will beshut off to prevent an overflow condition, which constitutes a safetyhazard. As shown in FIG. 3, liquid level sensors 114, 116, and 118 canbe attached to the local reservoir, e.g., a trough. A low level sensor114 indicates when the liquid resides at 20% of the capacity of thelocal reservoir; a full level sensor 116 indicates when the liquidresides at 80% of the capacity of the local reservoir; and an overfillsensor 118 indicates when the liquid resides at 100% of the capacity ofthe local reservoir. In FIG. 3, the arrows designated by the letter “F”indicate the direction of flow of the bulk liquid. When arrow has twoheads, the bulk liquid can flow in two directions.

The controller 102 for the bulk liquid handling system, hereinafteralternatively referred to as a bulk liquid handling controller,maintains the level of liquid in a local reservoir 104, e.g., a trough,on the deck supporting the aspirating/dispensing device. The bulk liquidhandling controller 102 prevents overflow conditions from occurring atthe local reservoirs 104, particularly troughs. The bulk liquid handlingcontroller 102 allows access to the local reservoirs 104 by theaspirating/dispensing device. The bulk liquid handling controller 102maintains the level of liquid without interaction from a real timecontroller.

The bulk liquid handling controller 102 tracks the volume of liquidremaining in the containers of bulk liquids. The bulk liquid handlingcontroller 102 allows for continuous access to replace containers ofbulk liquids. The bulk liquid handling controller 102 eliminates theneed to prime channels after replacing containers of bulk liquids, suchas, for example, bottles of bulk liquids. The bulk liquid handlingcontroller 102 allows for the disposal of troughs at specifiedintervals. The bulk liquid handling controller 102 handles removal ofliquid waste. The bulk liquid handling controller 102 provides access ooptional liquid-handling accessories, such as, for example, anARCHITECT® Automatic Reconstitution Module. The ARCHITECT® AutomaticReconstitution Module is an accessory that automatically dilutesconcentrated wash buffer to the proper concentration and delivers it toa wash buffer reservoir. The ARCHITECT® Automatic Reconstitution Moduleis described in greater detail in ARCHITECT System Operations Manual (PN201837-106) January 2009, pages 1-143 through 1-148, incorporated hereinby reference. The bulk liquid handling controller 102 provides thecapability to clean local reservoirs, e.g., troughs. A plurality ofchannels can be used for various different types of bulk liquids, suchas wash buffer, water, pre-trigger solution, and the like. Each channelis capable of operating independently first channel can be maintainingthe level of liquid in a trough while a second channel can be employinga cleaning solution in the cleaning step of a maintenance procedure).

Control by means of the bulk liquid handling controller 102 allows thebulk liquid handling sub-system 100 to be activated or deactivated by areal time controller of a higher level system. The real time controllercan request the status of the bulk liquid handling sub-system 100 orinitiate a cleaning procedure. This control architecture would free thereal time controller from the details of the operations of hulk liquidhandling. FIG. 4 shows the relationship between the system for handlingbulk liquids and the real time controller of a laboratory automationsystem. Real time control between a laboratory automation system and abulk liquid handling sub-system allows a laboratory automation systemand the bulk liquid handling system to coordinate their functions. Forexample, when a liquid in a container of bulk liquid is to betransferred to a local reservoir, a message is sent to the bulk liquidhandling system. Then the bulk liquid handling system sends a message tothe laboratory automation system to move the liquid from the containerof bulk liquid to the appropriate local reservoir. Real time control isfurther described in Stewart. Introduction to Real Time, EmbeddedSystems Design—Embedded.com, Nov. 1, 2001, at the world wide web athttp://www.embedded.com/story/OEG20011016S0120, incorporated herein byreference.

As shown in FIG. 4, a system control center, i.e., real timecontroller.200 includes software for an absorbance reader 202, softwarefor a luminescence reader 204, software for magnetic particle processing206, software for an aspirating/dispensing device 208, software for abulk liquid handling sub-system 210, and software for motor controller212. The aforementioned software is connected to system software bymeans of appropriate interfaces. The system control center 200 isconnected to an 8-axis motion controller 214 by means of an appropriateinterface. The eight-axis motion controller 214 is connected to a platerotator 216, a first microparticle reagent dispersing apparatus 218,second microparticle dispersing apparatus 220, and a magnetic particleprocessing tray 222 by means of appropriate interfaces. The platerotator 216, i.e., the location where dispensing is carried out, isconnected to a temperature controller 224 by an appropriate interface.Also shown in FIG. 4 are a first serial expansion component 226 and asecond serial expansion component 228. The first serial expansioncomponent 226 is connected to at least one absorbance reader 230, to atleast one luminescence reader 232, to at least one magnetic particleprocessor 234, and to at least one radio frequency identificationreader/writer 236. The connections between the first serial expansioncomponent 226 and the components attached thereto are made byappropriate interfaces, such as, for example, RS-232 connectors. Thesecond serial expansion component 228 is connected to at least one radiofrequency identification antenna select board 238, to at least one ofthe temperature controllers 224, and to a bulk liquid handlingcontroller 240. The connections between the second serial expansioncomponent 225 and the components attached thereto are made byappropriate interfaces, such as, for example, RS-232 connectors. Anothercomponent shown in FIG. 4 is a temperature controller 242, which isconnected to the at least one magnetic particle processor 234 by anappropriate interface. Still another component connected to the systemcontrol center 200 is a four-channel XYZ aspirating/dispensing apparatus244. The first serial expansion component 226, the second serialexpansion component 228, and the four-channel XYZ aspirating/dispensingapparatus 244 are connected to the system control center 200 by means ofappropriate interfaces, such as, for example, USB connectors.

Referring now to FIGS. 5, 6, 7, 8, 9, 10, 11, and 12, a mechanism 300for loading troughs 302 comprises a holder 304 for supporting aplurality of troughs 302. The holder 304 is mounted upon a support 306.A first lever arm 308 and a second lever arm 310, one on each side ofthe support 306, are connected by a rod 312. The combination of thefirst lever arm 308, the second lever arm 310, and the rod 312 allowsthe operator to rotate a set of paddles 314. Although two lever arms areshown in FIGS. 5, 6, 7, and 8, the rotation called for can be carriedout by means of a single lever arm. Each paddle 314 supports threesensors 316 a, 316 b, 316 c for each trough 302. In addition, tubes 318for filling and/or draining the troughs 302 are raised when the paddles312 are rotated to abut the troughs 302 and lowered when the paddles 314are rotated away from the troughs 302. Locking mechanisms 320 a, 320 bfor the first lever arm 308 and the second lever a 310, respectively,can be used to lock the first lever arm 308 and the second lever arm310, respectively, to retain the paddles 314 in a specified position.The locking mechanisms 320 a, 320 b can easily be disengaged from thefirst lever arm 308 and from the second lever arm 310, respectively,toenable the paddles 314 to be rotated away from the troughs 302. Eachtrough 302 has three receptacles 322 a, 322 b, 322 c for containing aninterface material (not shown) for the sensors 316 a, 316 b and 316 c.This interface material is protected by a peelable protective strip 326,which can be removed prior to loading the trough 302 into the troughloading mechanism 300. The design of the trough 302 can optionallyprovide for a slip-in divider wall 326, which aids in guiding the tubes318 in filling and/or draining the troughs 302.

The components of the trough loading mechanism 300 and the troughs 302themselves are typically made of a durable, corrosion resistantmaterial, such as, for example a polymeric material or a corrosionresistant metal or alloy. The trough loading mechanism 300 can beoperated manually by a human operator or can be operated automaticallyby a robotic mechanism. The locking mechanisms 320 a, 320 b shown inFIGS. 5, 6, 7, 8, and 9 are more suitable for human operators in thateach of these locking mechanisms 320 a, 320 b employ locking plates 328a, 328 b, respectively, having an aperture therein. When the aperturesof the locking plates 328 a, 328 b are in register with apertures formedin the first lever arm 308 and the second lever 310, respectively, thehuman operator can insert bolts 330 a 330 b through the apertures in thelocking plates 328 a, 328 b and through the apertures in the first leverarm 308 and the second lever arm 310, thereby locking the first leverarm 308 and the second lever arm 310 in a specified position.

As shown in FIGS. 5, 6, 7, 8, 9, and especially in FIGS. 10, 11, and 12,each trough 302 has a base 302 a, two elongated side walls 302 b, 302 carising from the base 302 a, and two end walls 302 d, 302 e arising fromthe base 302 a. As an alternative to using the tube 318 to drain thetrough, the trough 302 can be drained by opening an aperture (not shown)in the base 302 a of the trough 302.

In an alternative embodiment, the trough loading mechanism 300 is notrequired. In this alternative embodiment, shown FIG. 13, a trough 402 issupported by a holder 404. The holder 401 is mounted on a support (notshown). The trough 402 has a base 402 a, two elongated sidewalks 402 b,402 c arising from the base 402 a, and two end walls 102 d, 402 earising from the base 402 a. The trough 402 can be drained by opening anaperture (not shown) in the base 402 a of the trough 402.

The trough 402 does not have receptacles for receiving liquid levelsensors. In this embodiment, shown in FIGS. 13 and 14, the holder 404has three apertures 404 a, 404 b and 404 c formed in one end 404 d ofthe holder 404. Each aperture 404 a, 404 b, and 404 c is capable ofallowing a liquid level sensor 422 a, 422 b, and 422 c, respectively, topass therethrough in order to eatable the liquid level sensors 422 a,422 b, and 422 c to be attached to the end wall 402 d of the trough 402.Attachment of the liquid level sensors 422 a, 422 b, and 422 c to theend wall 402 d of the trough can be effected by means of an adhesive.The liquid level sensors 422 a, 422 b, and 422 c are secured to the endwall 402 d of the trough 402 by means of an arrangement comprisingsprings 432 a, 432 b, and 432 c, which springs are held in place by apressure plate 434. The pressure plate 434 is fastened to the end 404 dof the holder 404 by a set of bolts 436 a, 436 b, 436 c, and 436 d. Theliquid level sensors 422 a, 422 b, and 422 c are of such a design thatthey do not require receptacles on the end wall 402 d of the trough 402in order to function. Such liquid level sensors are commerciallyavailable from Moog, Inc., Salt Lake City, Utah under the designationLifeguard™ Point Level Sensor. In this embodiment, a tube for fillingthe trough 402 is not shown. However, it should be apparent one ofordinary skill in the art any of several ways to set up a tube forfilling the trough 402,

Bulk liquids, such as, for example, a pre-trigger solution for certaintypes of immunoassays, wash buffer, and deionized water, are preferablycontained in troughs, so that a plurality of pipette tips can aspirate aspecific liquid simultaneously. The purpose of the pre-trigger solutionis to enable the release of a chemiluminescent material, e.g.,acridinium, from the conjugate that has bound to the magneticmicroparticles in an immunoassay. In addition, the pre-trigger solutionadds hydrogen peroxide and lowers the pH to a level so that no photonsare emitted from the chemiluminescent material. A trigger solutioncomplementary to the pre-trigger solution raises the pH back to neutralby means of a basic solution, e.g., sodium hydroxide solution, andallows the hydrogen peroxide to generate photons from thechemiluminescent material. Dispensing of bulk liquids can also beperformed by a sub-system on the analysis section 10 in order to reducethe burden of the aspirating/dispensing device 92. As shown in FIGS. 1and 2, the area 46 of the analysis section 10 can accommodate six (6)troughs. The number of troughs that can be accommodated by the area 46of the analysis section 10 is not critical. The numbers set forthpreviously are merely representative examples for a typical arrangement.Other bulk liquids can be stored where appropriate. For example, thetrigger solution for certain types of immunoassays, which is used inconjunction with the pre-trigger solution, can be stored in a reader,such as, for example, a luminescence reader, whereby the triggersolution is released at the point when the results of the assay are tobe read. The trigger solution enables photons to be emitted from thelabel of the reaction product of the immunoassay within from about three(3) to about five (5) seconds.

To ensure that each bulk liquid is loaded into the correct location, aradio frequency identification antenna is positioned on the base of eachcontainer of bulk liquid. The radio frequency identification antenna canread the radio frequency identification tag attached to the base of eachcontainer. The recess receives and holds a container of hulk liquid,and, in addition, provides positive registration of the position of thecontainer of bulk liquid. An antenna is located at bottom of the recessfor each container for bulk liquid. When a container is loaded into arecess, the identity of the container can be verified by reading theradio frequency identification tag attached to the base of thecontainer.

In addition, restrictive tubing lengths and divider walls betweencontainers can be used to prevent bulk liquid straw assemblies frombeing inserted into incorrect containers of bulk liquids. By limitingthe lengths of tubing and providing divider walls/recesses for each bulkliquid bottle, the appropriate straw assembly can be placed into thecorrect bottle only.

The bulk liquid handling software resides on a bulk liquid handlingcontroller. The software operates in the following manner.

Power is applied to the sub-system, at which point the system boots up,runs a self test, initializes communication, sets all channels toINACTIVE, and waits for commands. The real time controller requests thecurrent status of the sub-system.

The bulk liquid handling sub-system can report the status of eachchannel, but the volumes of bulk liquids remaining in containers of bulkliquids are not reported for channels that were not initialized at avolume greater than zero in a container of bulk liquid upon receiving aRUN command Each local reservoir is associated with a channel of thebulk liquid handling sub-system. The controller for the bulk liquidhandling sub-system does not retain records of volumes of liquids incontainers of bulk liquids after a shut-down of power. If a non-zerovalue for the level of a liquid in a container is not provided via a RUNcommand, the bulk liquid handling controller does lot have any volume ofliquid from which to subtract a value when a volume of liquid from acontainer of bulk liquid is consumed.

Based on the status of the bulk liquid handling sub-system, the realtime controller may send a RUN command to the hulk liquid handlingsub-system to maintain the level of liquid of each local reservoir atthe proper level and to initialize volumes of liquids remaining in thecontainers of bulk liquids. When the bulk liquid handling controllerreceives a RUN command, the hulk liquid handling controller can begincontrolling liquid level between the levels of low and full for eachlocal reservoir, e.g., trough, commanded. In addition, the bulk liquidhandling controller can subtract the value of the volume of liquidconsumed from the value of the starting volume as liquids arc consumed.

The real time controller can determine if an accessory, such as, forexample, an ARCHITECT® Automatic Reconstitution Module, is present andsend this information to the bulk liquid handling controller, along withstarting volumes of liquid in all of the containers of bulk liquids.

When a container becomes empty, the bulk liquid handling controller caninternally change the status of the container and disable the channel(s)affected.

The bulk liquid handling controller can determine that the container ofbulk liquid is empty by timing the fill operation to move the level ofliquid from low to full in a local reservoir, e.g., a trough. If theexpected filling time is exceeded and the level of liquid in the bulkcontainer is below the low sensor, the bulk liquid handling sub-systemcan interpret this measurement to mean that the container of bulk liquidis empty.

Periodically, the real time controller can request the status of he bulkliquid handling sub-system from the bulk liquid handling controller. Thereal time controller can interpret the status returned from the bulkliquid handling controller and determine whether a container of bulkliquid is empty. Then, the real time controller can instruct theoperator to replace the container of bulk liquid. The real timecontroller can send a RUN command, with the value of the new startingvolume of the container of bulk liquid, indicating that the fault, i.e.,empty container of bulk liquid, has been corrected. A fault messagedisables a channel.

The bulk liquid handling controller can check to determine whether theliquid level sensor for the container of bulk liquid was reconnected andwhether the low sensor for the container of bulk liquid is activated(i.e., the container is not empty; the container contains a minimumamount of liquid) before re-enabling the previously disabled channelsand continuing to maintain the levels of liquid.

The real time controller can send a STOP command along with specificidentifiers for various channels. The real time controller can instructthe operator to insert all connections of the containers of bulk liquidinto one container of bulk liquid that contains a cleaning solution. Thereal time controller can send a CLEAN command for the specific channelsthat need to be cleaned or replaced. The bulk liquid handling sub-systemcan fill the specific local reservoirs, troughs, with the cleaningsolution up to the low sensor level and then stop. The real timecontroller can then wait to allow the liquid lines o soak and then senda DRAIN command identifying the specific channels to drain. The bulkliquid handling sub-system can completely empty the specific localreservoirs, troughs, so identified. The real time controller caninstruct the operator to insert all connections for containers of bulkliquids into one container containing deionized ate The real timecontroller can send a CLEAN command for the specific channels that needto be cleaned or replaced. The bulk liquid handling sub-system can fillthe local reservoirs, e.g., troughs, with deionized water up to the lowlevel sensor and then stop. The real time controller can then wait toallow the liquid lines to soak and then send a DRAIN command to thechannels specified. The bulk liquid handling sub-system can completelyempty the specific local reservoirs, e.g., troughs. The real timecontroller can repeat cleaning with deionized water as many times asspecified.

The real time controller can instruct the operator to re-insert theconnections to the containers into the original containers of bulkliquids. The real time controller can instruct the operator to disengagethe sensors and liquid connections from the local reservoirs, e.g.,troughs, and dispose of the local reservoirs, e.g., troughs. The realtime controller can instruct the operator to replace the localreservoirs, e.g., troughs, and to engage the liquid level sensors andliquid connections. The bulk liquid handling controller manages pumpsand valves (if the valves are electronic) to drain local reservoirs to awaste container or to a drain.

During draining, if the waste container becomes full, the bulk liquidhandling controller can internally change the status of the channels anddisable the channels that require removal of waste. Periodically, thereal time controller can request the status of the bulk liquid handlingsub-system from the bulk liquid handling controller. The real timecontroller can interpret the status of the bulk liquid handlingsub-system returned from the bulk liquid handling controller anddetermine whether the waste container is full. The real time controllercan instruct the operator to empty the waste container. The real timecontroller can also send a DRAIN command to the bulk handlingcontroller, indicating that the fault was corrected.

The bulk liquid handling controller can check to determine whether thewaste sensor has been reconnected and whether the waste container isstill not full before continuing to drain the local reservoirs, e.g.,troughs.

The bulk liquid handling sub-system maintains the level of liquids inthe various local reservoirs, e.g., troughs. The bulk liquid handlingsub-system prevents overflows from the local reservoirs, e.g., troughs.The real time controller enables the aspirating/dispensing device toaccess the troughs. The bulk liquid handling controller allows the levelof liquid in the local reservoirs, e.g., troughs, to be maintainedwithout interaction from a real time controller. The bulk liquidhandling controller tracks the volume of liquid remaining in thecontainers of bulk liquids. The bulk liquid handling sub-system allowsan operator continuous access to replace containers of bulk liquids. Thebulk liquid handling sub-system eliminates the need to prime channelsafter containers containing bulk liquids are replaced. The bulk liquidhandling sub-system allows for disposal of local reservoirs, e.g.,troughs, at specified intervals. The bulk liquid handling sub-systemhandles removal of liquid waste. The bulk liquid handling sub-systemprovides access to optional accessories, such as, for example, theARCHITECT® Automatic Reconstitution Module. The bulk liquid handlingsub-system provides the capability to clean local reservoirs, e.g.,troughs. The bulk liquid handling sub-system allows each channel to beoperated independently. For example, a first channel can be maintainingthe level of liquid in a given trough while a second is being cleanedwith a cleaning solution.

Various modifications and alterations of this disclosure will becomeapparent to those skilled in the art without departing from the scopeand spirit of this disclosure, and it should be understood that thisdisclosure is not to be unduly limited to the illustrative embodimentsset forth herein.

What is claimed is:
 1. A system to handle a bulk liquid in a diagnosticanalyzer, the system comprising: a first container having a bulk liquid;a second container to dispense the bulk liquid; a fluid conduit tofluidly couple the first container and the second container; at leastone of a valve or a pump operably coupled to the fluid conduit; and acontroller to control the at least one of the valve or the pump totransfer the bulk liquid from the first container to the secondcontainer.
 2. The system of claim 1 further comprising a firstaspirating/dispensing device to dispense the bulk liquid from the secondcontainer into a first reaction vessel of an automated diagnosticanalyzer.
 3. The system of claim 2 further comprising a pre-treatmentarea where the first reaction vessel is disposed when the firstaspirating/dispensing device is to dispense the bulk liquid into thefirst reaction vessel, the pre-treatment area being located above thefirst container of the bulk liquid.
 4. The system of claim 3 furthercomprising a waste container to receive liquid waste from the automateddiagnostic analyzer, the pre-treatment area being located above thewaste container.
 5. The system of claim 2 further comprising a secondaspirating/dispensing device to dispense the bulk liquid from the secondcontainer into a second reaction vessel of the automated diagnosticanalyzer.
 6. The system of claim 5, wherein the first and secondaspirating/dispensing devices are to aspirate the bulk liquid from thesecond container simultaneously.
 7. The system of claim 1 furthercomprising a liquid level sensor to determine an amount of the bulkliquid that is in the second container.
 8. The system of claim 7,wherein the liquid level sensor is communicatively coupled to thecontroller, and the controller is to control the at least one of thevalve or the pump to transfer the bulk liquid from the first containerto the second container when the liquid level sensor indicates theamount of bulk liquid in the second container is below a threshold. 9.The system of claim 7, wherein the sensor coupled to an outer surface ofthe first container.
 10. The system of claim 1, wherein the secondcontainer is a trough having an open top.
 11. A method comprising:sensing a level of bulk liquid in a reservoir disposed in an automateddiagnostic analyzer; operating, via a controller, a valve to transfer atleast a portion of the bulk liquid from a container to the reservoir,the container being fluidly coupled to the reservoir via a fluidconduit, the valve operably coupled to the fluid conduit; and operating,via the controller, the valve to transfer at least a portion of the bulkliquid from the reservoir to a waste container or drain.
 12. The methodof claim 11, wherein sensing the level of the bulk liquid in a reservoircomprises sensing the level of the bulk liquid via a sensor coupled toan outside of the reservoir.
 13. The method of claim 12, wherein thesensor comprises three sensors, including a low level sensor to indicatewhen the bulk liquid is at or below a low threshold of a capacity of thereservoir, a full level sensor to indicate when the bulk liquid is at orabove a high threshold of the capacity of the reservoir and an overfillsensor to indicate when the bulk liquid is at or near 100% of thecapacity of the reservoir.
 14. The method of claim 12, wherein thesensor is a capacitive sensor.
 15. The method of claim 11, wherein thereservoir comprises a trough having an open top.